LINCOLNSHIRE, Ill., June 30, 2005 – Takeda Pharmaceuticals North America today announced that the company has submitted a New Drug Application (NDA) for a new oral medication that combines pioglitazone HCl and glimepiride, a sulfonylurea, to the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. Takeda submitted a separate NDA for a combination of pioglitazone HCl and metformin HCl in October 2004.

ACTOS® (pioglitazone HCl) directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces. Glimepiride acts primarily by increasing the amount of insulin produced by the pancreas. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels. The company is seeking approval to bring the medication to market in the United States.

According to the American Diabetes Association, diabetes affects an estimated 18.2 million Americans. Type 2 diabetes is the most common form, and may account for about 90 to 95 percent of all diagnosed cases of diabetes.

About ACTOS

ACTOS, an insulin sensitizer belonging to the thiazolidinedione (TZD) class of oral antidiabetic medications, directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. ACTOS is taken once daily as an adjunct to diet and exercise, and is approved for type 2 diabetes for use as monotherapy to lower blood glucose and in combination therapy with insulin, sulfonylureas or metformin.

Additional Information

ACTOS is not for everyone. ACTOS can cause fluid retention that may lead to or worsen heart failure, so tell your doctor if you have a history of these conditions. Talk to your doctor immediately if you experience rapid weight gain, fluid retention, or shortness of breath while taking ACTOS. If you have moderate to severe heart failure, ACTOS is not recommended. Your doctor should perform a blood test to check for liver problems before you start ACTOS and periodically thereafter.

Do not take ACTOS if you have active liver disease. Talk to your doctor immediately if you experience nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine, or yellowing of the skin. If you are of childbearing age, talk to your doctor before taking ACTOS as it could increase your chance of becoming pregnant. Some people taking ACTOS may experience flu-like symptoms, mild to moderate swelling of legs and ankles, and anemia. When taking ACTOS with insulin or sulfonylureas, you may be at risk for low blood glucose.

About glimepiride

Glimepiride is a prescription blood glucose-lowering drug of the sulfonylurea class. Side effects seen with glimepiride include hypoglycemia (blood glucose of <60 mg/dL), which may become more severe. Patients taking glimepiride should be aware of the signs and symptoms of hypoglycemia which may include shakiness, nervousness, sweating, hunger, headache, nausea, asthenia (loss of strength) and dizziness.

Glimepiride should not be taken by patients with hypersensitivity to the drug or with diabetic ketoacidosis. Glimepiride should be discontinued in nursing mothers. Administration of an oral hypoglycemic drug similar to glimepiride has been associated with increased cardiovascular mortality as compared to treatment with diet and exercise alone or diet plus insulin. Patients should always talk with their health professional about all the prescription and over-the-counter medications and dietary supplements they are taking before starting a new prescription.

Source: Eurekalert & others

Last reviewed:
By John M. Grohol, Psy.D. on
21 Feb 2009
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